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CAPA (Corrective and Preventive Action) Specialist

Oro Valley, AZ 85755

Posted: 11/08/2023 Employment Type: Contract Industry: Administration Job Number: 11475 Pay Rate: $35.00 - $48.00

Job Description

Our client develops, manufactures, and supplies a wide array of innovative medical diagnostic products, services, tests, platforms, and technologies.

Job Overview:
  • The CAPA (Corrective And Preventive Action) Specialist is the CAPA System Quality Representative and coordinates the inputs and outputs of the System. Acts as the company liaison to their Global CAPA Committee.
  • Advocates for Ventana's Quality System technical and functional needs with respect to the systems developed for CAPA and designated by Roche corporate for use at the Ventana site.
  • As the Key User and Subject Matter Expert (SME) for the CAPA Tracking System, the individual monitors and reports on its function to corporate.
  • Coordinates all improvement projects for the CAPA System, ensuring their alignment with the company's organizational goals.
  • Leads the development of and implements training for all users of the System, as their functional positions require.
  • This position drives system improvements to increase product/process quality and organizational efficiency.

Responsibilities:
  • Coordinates the activities of the CAPA Review Board to ensure the communications of the Board are recorded and the quality records produced by the Board are maintained per procedure.
  • Participates in the review and documentation of issues as they are escalated to the CAPA System.
  • Monitors work performed by participants of the CAPA System to ensure that those quality records are generated and maintained according to procedure.
  • Gathers and reports measurable data for periodic reviews of the Quality System.
  • Collaborates with departmental managers to track data and analyze trends reported at Management Review.
  • Provides support for Translational Diagnostics, Manufacturing, R&D, Quality Assurance, and Operations as required to ensure
  • regulatory compliance, appropriate business planning, and continuously promoting Quality First Time.
  • Participates in the development and maintenance of processes/procedures for ensuring compliance to internal and external requirements.
  • Provides internal support for review of policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including quality system standards such as 21 CFR Parts 820 and ISO 13485/9000, etc.
  • Leads outreach support of quality system concepts and tools as they are applied throughout the company.
  • Supports communications with scientific and Regulatory bodies as necessary.

Job Requirements

Qualifications:
  • Bachelor's Degree in business management, biological science, engineering
  • field or related discipline.
  • Equivalent combination of education and experience will be considered.
  • Demonstrated proficiency with domestic and international regulations.
  • Knowledge of process design and implementation, change control, auditing, and document management systems.
  • Strong interpersonal and organizational skills.
  • Ability to work in fast-paced setting and cross-functionally with all levels of employees.
  • Excellent oral and written communication skills. Ability to prepare and present information to groups.
  • High degree of initiative with the ability to work independently, maintaining accuracy and quality.
  • Good use of process and business judgment.
  • Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
  • Able to develop and implement quality programs, including tracking, analyzing, reporting and problem-solving.
  • Able to plan, control and assure product and process quality.
  • Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, corrections, corrective, and preventive actions, and how to overcome barriers to quality improvements.
  • Knowledge of word processing, spreadsheets, databases and PowerPoint presentations.

Meet Your Recruiter

Jay Hite
Recruiter, Account Manager

As a Recruiter at Compass, Jay enjoys meeting job seekers and helping them to find new and exciting opportunities. He enjoys the process of getting to know candidates and learning all about their experience and what their future goals are. Jay feels the excitement of his candidates and is passionate about helping to find a fit both culturally and professionally. 

When Jay isn’t working, he enjoys bike rides, trying out new foods, tequila tasting and watching movies.  

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